MAUDE Adverse Event Report: ARTHREX, INC. 9.5 MM FLIP CUTTER II; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	9.5 MM FLIP CUTTER II
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that during femoral drilling, the blade of the device broke off in the joint.Everything could be removed completely.There was no harm or adverse event for patient, operator or third party reported.The anterior cruciate ligament knee surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-1204af-95 (no batch indicator present) was received for investigation.The cutting tip at the distal end of the shaft had broken, and the remnants were no longer functional.The fragments generated during the event were not returned for analysis.The observed condition is most likely the result of prying/leveraging the device during use.

• Brand Name: 9.5 MM FLIP CUTTER II
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11398337
• Report Number: 1220246-2021-02665
• Device Sequence Number: 3523916
• Product Code: HWE
• UDI-Device Identifier: 00888867004276
• UDI-Public: 00888867004276
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 9.5 MM FLIP CUTTER II
• Device Catalogue Number: AR-1204AF-95
• Device Lot Number: 719975885
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/10/2021
• Supplement Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 03/02/2021
• Supplement Report FDA Received Date: 06/04/2021
• Patient Sequence Number: 1